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Partially-guided Protocol for Maxillary Overdentures Retained by Ti-Zr One-piece Mini Implants (SMIS-Max)

Primary Purpose

Edentulous Jaw, Implant Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implant placement surgery
Sponsored by
Universidade Federal de Goias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Jaw focused on measuring Dental implant, Overdenture, Edentulous patient, Clinical study, Effectiveness

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥ 60 years of age healed dentulous maxillary arch (minimum of twelve weeks since the last extraction) wearing a complete maxillary denture evaluated as sufficient for surgical planning minimal ridge dimensions of 5.4 mm (width) by 12 mm (height) in the anterior and premolar maxillary area bone dimensions allowing the placement of one-piece implants with a 2.4 mm-diameter and minimum length of 10 mm. general health condition should be a physical status ASA1 or ASA2. Exclusion Criteria: inability to perform adequate oral hygiene incapability to provide written informed consent and compliance to the protocol any contraindication for oral surgery such as but not limited to, uncontrolled diabetes immunosuppression radiation or chemotherapy antiresorptive medication such as bisphosphonates presence of dental, periodontal or peri-implant disease in the opposing arch presence of a conventional complete denture in the opposing arch (mandible) presence of an insufficient partial removable denture or implant-overdenture in the opposing arch, which cannot be rendered sufficient by a reline heavy smoking habit with > 20 cig/d reported severe bruxism or clenching habits clinically present oro-facial pain depression with a Geriatric Depression Scale above 12 xerostomia with a stimulated salivary flow rate inferior to 0.7 ml/min ridge morphology type IV (Cawood and Howell, 1988) defects requiring bone augmentation procedures, or unhealthy soft tissues.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    One-piece titanium-zirconium mini implants

    Arm Description

    Six one-piece titanium-zirconium mini implants (Straumann® Mini Implant System, Institut Straumann AG, Switzerland) in the edentulous maxilla, using a partially-guided insertion protocol.

    Outcomes

    Primary Outcome Measures

    Accuracy of implant placement
    Assessment of the accuracy of the methods will be based on the measure of the difference between the actual and the planned position of the mini implants, based on the measurement of (1) the global deviations at the coronal and apical regions of the mini implants, (2) the vertical deviation, and (3) the apical angle deviation. The global deviation is defined as the 3D distance between the coronal/apical centers of the planned and placed implants. The vertical deviation is the distance between the coronal center of the longitudinal axis of the planned implant and a plane parallel through the coronal center of the placed implant. The angle deviation will be measured as the angular divergence between the longitudinal axes of the planned and actual position of the mini implants. The divergence of the implant axis (in degrees) will also be recorded.
    Surgery intercurrencies and complications
    Any complications associated with the surgical procedures, or deviations from the prescribed protocol due to surgical intercurrences will be recorded. These include failed drilling of the planned implant site, need to raise a flap for adequate positioning of the needle drill, fracture of the bone walls, insufficient insertion torque (< 10 Ncm), early implant failure, and others.
    Treatment intercurrencies and complications
    Any post-treatment complications associated with the use of the maxillary overdenture
    Oral health-related quality of life impacts
    Overall impacts of treatment on oral health-related quality of life will be assessed using the Oral Health Impact Profile instrument for edentulous subjects (OHIP-EDENT). It contains 19 questions in seven domains and proved to be sensitive to changes in prosthetic treatment and oral health. For each of the questions, subjects are asked how frequently they have experienced the event during the last month. Responses are given on a 5-item Likert scale. In this study, the validated Portuguese translation of the questionnaire will be utilized.
    Oral health-related quality of life impacts
    Overall impacts of treatment on oral health-related quality of life will be assessed using the Oral Health Impact Profile instrument for edentulous subjects (OHIP-EDENT). It contains 19 questions in seven domains and proved to be sensitive to changes in prosthetic treatment and oral health. For each of the questions, subjects are asked how frequently they have experienced the event during the last month. Responses are given on a 5-item Likert scale. In this study, the validated Portuguese translation of the questionnaire will be utilized.
    Denture Satisfaction Index
    Denture satisfaction will be evaluated by using the Denture Satisfaction Index (DSI; (25)), a 10mm visual analogue scale (VAS)-based questionnaire. This index evaluates ease of cleaning, general satisfaction, speech, comfort, aesthetics, stability, chewing ability, function and the general oral condition.
    Denture Satisfaction Index
    Denture satisfaction will be evaluated by using the Denture Satisfaction Index (DSI; (25)), a 10mm visual analogue scale (VAS)-based questionnaire. This index evaluates ease of cleaning, general satisfaction, speech, comfort, aesthetics, stability, chewing ability, function and the general oral condition.
    Implant Survival and Success
    Implant Survival and Success rate will be defined as followed: I - Success (optimum health) II - Satisfactory survival III - Compromised survival IV - Failure (clinical absolute failure) Any of following Additionally, fractured implants will be considered as failures, except fracture of the implant apex during implant placement. Any dental implant showing excessive bone loss, such as radiolucency or infection, shall be treated in the manner best suited to the well-being of the subject, including treatment to save the dental implant.
    Prosthetic Success and Survival
    One of the following: Patrix fracture Dislodged, worn or loose matrix housing Matrix replacement Matrix fracture Fracture of the implant-supported overdenture Fracture of the acrylic above a patrix Fracture of denture teeth Relining of implant overdenture A failure will be defined as an event leading to the loss of the reconstruction and need for the fabrication of a new overdenture.

    Secondary Outcome Measures

    Chewing efficiency
    Chewing efficiency will be evaluated with a two-color mixing ability test (28), where participants are given a two-colored chewing gum and are asked to chew the specimen for 20 chewing cycles. The resulting bolus is evaluated visually on a reference scale and opto-electronically using the Variance of Hue (VOH) (Halazonetis et al., 2013).
    Maximum voluntary bite force (MBF)
    The Gnathodynamometer DMD® (Kratos Equipamentos Industriais Ltda., Cotia - SP, Brazil) is utilized. It is a digital force gauge with an 8.6mm thick bite element. MBF is assessed bilaterally between the upper and lower first molar. The participant's task is to bite as hard as possible on the force gauge, but to stop clenching when she/ he starts feeling uncomfortable. A contra-lateral stabilizing element with identical thickness is used to preclude denture dislodgement. The peak force of three recordings carried out on each side will be used for analysis.
    Plaque index
    Measured at 4 sites per implant (mesial/distal/buccal/oral), according to the modified Mombelli's Plaque Index (Mombelli et al., 1987)
    Bleeding on probing
    Measured at 4 sites per implant (mesial/distal/buccal/oral), the following clinical parameters will be evaluated at baseline and each follow-up visit. Dichotomous score: yes x no
    Pocket probing depth
    Will be measured from the peri-implant mucosal margin to the bottom of the sulcus or pocket
    Width of the keratinized tissue
    The width of the keratinized tissue around implants will be measured and expressed in mm at the buccal sideated through a simple rule of three with NIH Image J V1.44.
    Peri-implant bone loss
    Intra-oral radiographs are exported and 4 parallel lines are drawn corresponding to the shoulder and the apical end of the implant on Adobe Photoshop Elements 2.0 (Adobe Systems Inc., San Jose, CA, USA). One line each is placed at the shoulder and apical end of the implant and the other two at the defined bone level on the mesial and distal aspect of the implant. Knowing the implant length and using the implant-shoulder as a reference point, bone levels can be calculated through a simple rule of three with NIH Image J V1.44.
    Implant Stability - Final insertion torque
    : after the implant is installed in its final position, the final torque of insertion will be recorded (Newtons per centimeter), as displayed during insertion with the handpiece, or measured using the manual calibrated torque gauge ratchet. Peak insertion torque: maximum achieved torque value during the implant insertion (in Newtons per centimeter). Periotest value: values will be categorized using the Periotest value ranges: 8 to 0: Good osseointegration; the implant can be loaded; 01 to 09: clinical examination is required; loading of the implant might or might not be possible, depending on implant type and clinical situation; 10 to 50: osseointegration is insufficient, the implant cannot be loaded.
    Implant Stability - Final insertion torque
    After the implant is installed in its final position, the final torque of insertion will be recorded (Newtons per centimeter), as displayed during insertion with the handpiece, or measured using the manual calibrated torque gauge ratchet.
    Implant Stability - Peak insertion torque
    The maximum achieved torque value during the implant insertion (in Newtons per centimeter).
    Implant Stability - Periotest value
    the Periotest® hand piece (Periotest®, Siemens AG, Bensheim, Germany) will be used with the head of the patient stabilized so that the implants were perpendicular to the floor, and the Periotest will be held parallel to the floor. The test point will be in the most gingival region of the Optiloc attachment, and each measurement will be performed 3 times and the average value will be recorded for each implant. In addition, values will be categorized using the Periotest value ranges: -8 to 0: Good osseointegration; the implant can be loaded; 01 to 09: clinical examination is required; loading of the implant might or might not be possible, depending on implant type and clinical situation; 10 to 50: osseointegration is insufficient, the implant cannot be loaded.
    Implant Stability - Periotest value
    the Periotest® hand piece (Periotest®, Siemens AG, Bensheim, Germany) will be used with the head of the patient stabilized so that the implants were perpendicular to the floor, and the Periotest will be held parallel to the floor. The test point will be in the most gingival region of the Optiloc attachment, and each measurement will be performed 3 times and the average value will be recorded for each implant. In addition, values will be categorized using the Periotest value ranges: -8 to 0: Good osseointegration; the implant can be loaded; 01 to 09: clinical examination is required; loading of the implant might or might not be possible, depending on implant type and clinical situation; 10 to 50: osseointegration is insufficient, the implant cannot be loaded.

    Full Information

    First Posted
    October 2, 2023
    Last Updated
    October 6, 2023
    Sponsor
    Universidade Federal de Goias
    Collaborators
    ITI International Team for Implantology, Switzerland, Institut Straumann AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06081192
    Brief Title
    Partially-guided Protocol for Maxillary Overdentures Retained by Ti-Zr One-piece Mini Implants
    Acronym
    SMIS-Max
    Official Title
    Accuracy and Clinical Outcomes of Titanium-zirconium One-piece Mini Implants Using a Partially-guided Surgery for Maxillary Overdentures: a Pilot Prospective Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    August 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal de Goias
    Collaborators
    ITI International Team for Implantology, Switzerland, Institut Straumann AG

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a single-center, single-group, prospective clinical trial testing a partially-guided protocol for placement of mini implants overdentures in the edentulous maxilla. Eligible participants will be subjects with an edentulous maxilla, wearing a conventional complete denture. Participants will receive six mini implants (Straumann® Mini Implant System, Institut Straumann AG, Switzerland) for retention of a maxillary overdenture. The six mini implant protocol will be virtually planned for an even distribution of the implants bilaterally, with a minimum of 5 mm distance between contiguous implants. The available lengths of the mini implants are 10, 12, and 14 mm, and the appropriate length will be selected according to the bony anatomical situation. In addition, the distribution and axial position of the mini implants will be planned to achieve the best biomechanical distribution and the most parallel position between implants, perpendicular to the occlusal plane and path of insertion of the prosthesis. The primary outcome will be the accuracy of the implant position using the partially-guided protocol. Assessment of the accuracy of the methods will be based on the measure of the difference between the actual and the planned position of the mini implants, based on the measurement of (1) the global deviations at the coronal and apical regions of the mini implants, (2) the vertical deviation, and (3) the apical angle deviation. Overall impacts of treatment on oral health-related quality of life will be assessed using the Oral Health Impact Profile instrument for edentulous subjects (OHIP-EDENT). Additional outcomes will include implant survival and success rates, incidence of prosthodontic complications and peri-implant measurements.
    Detailed Description
    Design This is a single-center, single-group, prospective clinical trial testing a partially-guided protocol for placement of mini implants overdentures in the edentulous maxilla. Study setting, trial registration, and funding This clinical trial will be conducted in the clinical setting of the School of Dentistry of the Federal University of Goias, Brazil. The research protocol will be previously submitted for ethical approval by the local Ethical Research Committee and will be registered prospectively at the ClinicalTrial.gov database before initiating patient recruitment. Participants Eligible participants will be subjects with an edentulous maxilla, wearing a conventional complete denture. They will be selected from the list of patients who received conventional treatment at least six months previously. The possible conditions of the mandibular arch will include fully dentate subjects, partially edentate wearing fixed or removable prostheses, fixed or removable implant-supported dentures, or a shortened dental arch. During the recruitment phase of the study, they will be informed about the treatment to be provided, details about the clinical trial, and the need for collaboration in the prescribed procedures and post-treatment follow-up visits over a minimum 1-year period. The selected participants will sign an informed consent form to participate in the study. Inclusion and exclusion criteria We will select participants ≥ 60 years of age, with an edentulous maxillary arch, wearing a complete maxillary denture evaluated as sufficient for surgical planning. At the implant site level, they should present a healed edentulous maxilla (minimum of twelve weeks since the last extraction), minimal ridge dimensions of 5.4 mm (width) by 12 mm (height) in the anterior and premolar maxillary area, allowing the placement of one-piece implants with a 2.4 mm-diameter and minimum length of 10 mm. General health condition should be a physical status ASA1 or ASA2. Excluded criteria will comprise the inability to perform adequate oral hygiene, incapability to provide written informed consent and compliance to the protocol, and any contraindication for oral surgery such as but not limited to, uncontrolled diabetes, immunosuppression, radiation, chemotherapy, or antiresorptive medication such as bisphosphonates, presence of dental, periodontal or peri-implant disease in the opposing arch, presence of a conventional complete denture in the opposing arch (mandible), presence of an insufficient partial removable denture or implant-overdenture in the opposing arch, which cannot be rendered sufficient by a reline, a heavy smoking habit with > 20 cig/d, reported severe bruxism or clenching habits, clinically present oro-facial pain, depression with a Geriatric Depression Scale above 12, xerostomia with a stimulated salivary flow rate inferior to 0.7 ml/min. At the implant site level, potential participants will be excluded if they present a ridge morphology type IV, defects requiring bone augmentation procedures, or unhealthy soft tissues. Intervention This prospective clinical trial will be conducted on maxillary edentulous patients recruited for treatment with six mini implants (Straumann® Mini Implant System, Institut Straumann AG, Switzerland) for retention of a maxillary overdenture. Surgical diagnostic will consist of a preoperative visit with a thorough examination of the patient's medical and dental history, and clinical and radiological assessment. This includes a preliminary OPT-tomography to determine ridge morphology and exclude patients with insufficient ridge dimensions before additional radiographic examinations. In case of a positive preliminary radiographical examination, the radiological analysis will be performed with a Cone Beam Computed Tomography (CBCT) radiograph of the maxillary arch. The existing denture will be marked with gutta-percha or composite spheres in the second premolar, canine and central incisor regions prior to image-taking for the purpose of spatial reference. The existing denture will be subsequently scanned with an intra-oral scanner (TRIOS; 3 Shape), and the STL file will be imported into an implant planning software (coDiagnostiX; Dental Wings GmbH) along with the DICOM files of the CBCT. The six mini implant protocol will be virtually planned for an even distribution of the implants bilaterally, with a minimum of 5 mm distance between contiguous implants. The available lengths of the mini implants are 10, 12, and 14 mm, and the appropriate length will be selected according to the bony anatomical situation. In addition, the distribution and axial position of the mini implants will be planned to achieve the best biomechanical distribution and the most parallel position between implants, perpendicular to the occlusal plane and path of insertion of the prosthesis. Outcomes Accuracy of implant placement The primary outcome will be the accuracy of the implant position using the partially-guided protocol. Assessment of the accuracy of the methods will be based on the measure of the difference between the actual and the planned position of the mini implants, based on the measurement of (1) the global deviations at the coronal and apical regions of the mini implants, (2) the vertical deviation, and (3) the apical angle deviation. The global deviation is defined as the 3D distance between the coronal/apical centers of the planned and placed implants. The vertical deviation is the distance between the coronal center of the longitudinal axis of the planned implant and a plane parallel through the coronal center of the placed implant. The angle deviation will be measured as the angular divergence between the longitudinal axes of the planned and actual position of the mini implants. For image assessment, post-operative CBCT will be performed six weeks after surgery using the same CBCT machine and protocol used for the pre-operative CBCT. The images of the pre- and post-operative CBCTs will be superimposed using the automated surface best fit matching with the iterative closest point algorithm in the treatment evaluation mode of the coDiagnostiX® software. The individual deviations for the six inserted mini implants will be measured (in millimeters) at the limit between the machined and SLA surface of the mini implant, and at the apex between the planned and actual implant positions. The divergence of the implant axis (in degrees) will also be recorded. Six separate superimposing scans of the CBCT image will be obtained for each of the mini implants inserted in each patient, and measurements of deviations and angulations will be done separately. Treatment intercurrencies and complications Any complications associated with the surgical procedures, or deviations from the prescribed protocol due to surgical intercurrences will be recorded. These include failed drilling of the planned implant site, need to raise a flap for adequate positioning of the needle drill, fracture of the bone walls, insufficient insertion torque (< 10 Ncm), early implant failure, and others. Patient-reported outcomes (PROs) Overall impacts of treatment on oral health-related quality of life will be assessed using the Oral Health Impact Profile instrument for edentulous subjects (OHIP-EDENT). This is a shorter version of the 49-item OHIP, and the validated Portuguese translation of the questionnaire will be utilized. Denture satisfaction will be evaluated by using the Denture Satisfaction Index (DSI), a 10mm visual analogue scale (VAS)-based questionnaire. This index evaluates ease of cleaning, general satisfaction, speech, comfort, aesthetics, stability, chewing ability, function and the general oral condition. Chewing efficiency Chewing efficiency will be evaluated with a two-color mixing ability test, where participants are given a two-colored chewing gum and are asked to chew the specimen for 20 chewing cycles. The resulting bolus is evaluated visually on a reference scale and opto-electronically using the Variance of Hue (VOH). Maximum voluntary bite force (MBF) The Gnathodynamometer DMD® (Kratos Equipamentos Industriais Ltda., Cotia - SP, Brazil) is utilized. It is a digital force gauge with an 8.6mm thick bite element. MBF is assessed bilaterally between the upper and lower first molar. The participant's task is to bite as hard as possible on the force gauge, but to stop clenching when she/ he starts feeling uncomfortable. The peak force of three recordings carried out on each side will be used for analysis. Implant Survival and Success Implant Survival and Success rate will be defined as followed: I - Success (optimum health) II - Satisfactory survival III - Compromised survival IV - Failure (clinical absolute failure) Any of following: Additionally, fractured implants will be considered as failures, except fracture of the implant apex during implant placement. Prosthetic Success and Survival During the prosthodontic examination, the implant-supported prostheses will be examined for any complications according to the 2015 ITI Treatment Guide: A failure will be defined as an event leading to the loss of the reconstruction and need for the fabrication of a new overdenture. Clinical Peri-implant Measurements At 4 sites per implant (mesial/distal/buccal/oral), the following clinical parameters will be evaluated at baseline and each follow-up visit: Plaque index and bleeding on probing; Pocket probing depth; width of the keratinized tissue around implants. Peri-implant bone height Intra-oral radiographs are exported and four parallel lines are drawn corresponding to the shoulder and the apical end of the implant on. One line each is placed at the shoulder and apical end of the implant and the other two at the defined bone level on the mesial and distal aspect of the implant. Knowing the implant length and using the implant-shoulder as a reference point, bone levels can be calculated through a simple rule of three with NIH Image J V1.44. Implant Stability Primary implant stability will be assessed by measuring the final and peak insertion torques, and the primary and secondary implant stability will be assessed using the Periotest® instrument. The Periotest® hand piece (Periotest®, Siemens AG, Bensheim, Germany) will be used with the head of the patient stabilized so that the implants were perpendicular to the floor, and the Periotest will be held parallel to the floor. The test point will be in the most gingival region of the Optiloc attachment, and each measurement will be performed 3 times and the average value will be recorded for each implant. Sample size: The sample size for this study will include 10 participants. A 20% increase in sample size will be adopted to account for patient dropout during the 1-year follow-up, and with no relevant impact on the study power. Therefore, the final sample will comprise of 12 participants, and 72 units at the implant-level. Data analysis: Descriptive statistics and bivariate tests for independent groups will be used to analyze differences between groups, according to the data distribution patterns. Subsequently, a Linear Mixed-Effects Model (LMM) regression will be used to test the effect of independent variables (anatomic and functional features) on the post-surgical accuracy of the implant position. This multi-level approach will be used because of the clustered effect of multiple implants within patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Edentulous Jaw, Implant Complication
    Keywords
    Dental implant, Overdenture, Edentulous patient, Clinical study, Effectiveness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single-center, single-group, prospective clinical trial
    Masking
    None (Open Label)
    Masking Description
    Not applied
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    One-piece titanium-zirconium mini implants
    Arm Type
    Experimental
    Arm Description
    Six one-piece titanium-zirconium mini implants (Straumann® Mini Implant System, Institut Straumann AG, Switzerland) in the edentulous maxilla, using a partially-guided insertion protocol.
    Intervention Type
    Procedure
    Intervention Name(s)
    Implant placement surgery
    Other Intervention Name(s)
    Dental implant
    Intervention Description
    Placement of six mini implants in the edentulous maxilla using a partially-guided protocol
    Primary Outcome Measure Information:
    Title
    Accuracy of implant placement
    Description
    Assessment of the accuracy of the methods will be based on the measure of the difference between the actual and the planned position of the mini implants, based on the measurement of (1) the global deviations at the coronal and apical regions of the mini implants, (2) the vertical deviation, and (3) the apical angle deviation. The global deviation is defined as the 3D distance between the coronal/apical centers of the planned and placed implants. The vertical deviation is the distance between the coronal center of the longitudinal axis of the planned implant and a plane parallel through the coronal center of the placed implant. The angle deviation will be measured as the angular divergence between the longitudinal axes of the planned and actual position of the mini implants. The divergence of the implant axis (in degrees) will also be recorded.
    Time Frame
    6 weeks
    Title
    Surgery intercurrencies and complications
    Description
    Any complications associated with the surgical procedures, or deviations from the prescribed protocol due to surgical intercurrences will be recorded. These include failed drilling of the planned implant site, need to raise a flap for adequate positioning of the needle drill, fracture of the bone walls, insufficient insertion torque (< 10 Ncm), early implant failure, and others.
    Time Frame
    6 weeks
    Title
    Treatment intercurrencies and complications
    Description
    Any post-treatment complications associated with the use of the maxillary overdenture
    Time Frame
    Through study completion, an average of 1 year
    Title
    Oral health-related quality of life impacts
    Description
    Overall impacts of treatment on oral health-related quality of life will be assessed using the Oral Health Impact Profile instrument for edentulous subjects (OHIP-EDENT). It contains 19 questions in seven domains and proved to be sensitive to changes in prosthetic treatment and oral health. For each of the questions, subjects are asked how frequently they have experienced the event during the last month. Responses are given on a 5-item Likert scale. In this study, the validated Portuguese translation of the questionnaire will be utilized.
    Time Frame
    6 months
    Title
    Oral health-related quality of life impacts
    Description
    Overall impacts of treatment on oral health-related quality of life will be assessed using the Oral Health Impact Profile instrument for edentulous subjects (OHIP-EDENT). It contains 19 questions in seven domains and proved to be sensitive to changes in prosthetic treatment and oral health. For each of the questions, subjects are asked how frequently they have experienced the event during the last month. Responses are given on a 5-item Likert scale. In this study, the validated Portuguese translation of the questionnaire will be utilized.
    Time Frame
    1 year
    Title
    Denture Satisfaction Index
    Description
    Denture satisfaction will be evaluated by using the Denture Satisfaction Index (DSI; (25)), a 10mm visual analogue scale (VAS)-based questionnaire. This index evaluates ease of cleaning, general satisfaction, speech, comfort, aesthetics, stability, chewing ability, function and the general oral condition.
    Time Frame
    6 months
    Title
    Denture Satisfaction Index
    Description
    Denture satisfaction will be evaluated by using the Denture Satisfaction Index (DSI; (25)), a 10mm visual analogue scale (VAS)-based questionnaire. This index evaluates ease of cleaning, general satisfaction, speech, comfort, aesthetics, stability, chewing ability, function and the general oral condition.
    Time Frame
    1 year
    Title
    Implant Survival and Success
    Description
    Implant Survival and Success rate will be defined as followed: I - Success (optimum health) II - Satisfactory survival III - Compromised survival IV - Failure (clinical absolute failure) Any of following Additionally, fractured implants will be considered as failures, except fracture of the implant apex during implant placement. Any dental implant showing excessive bone loss, such as radiolucency or infection, shall be treated in the manner best suited to the well-being of the subject, including treatment to save the dental implant.
    Time Frame
    Through study completion, an average of 1 year
    Title
    Prosthetic Success and Survival
    Description
    One of the following: Patrix fracture Dislodged, worn or loose matrix housing Matrix replacement Matrix fracture Fracture of the implant-supported overdenture Fracture of the acrylic above a patrix Fracture of denture teeth Relining of implant overdenture A failure will be defined as an event leading to the loss of the reconstruction and need for the fabrication of a new overdenture.
    Time Frame
    Through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Chewing efficiency
    Description
    Chewing efficiency will be evaluated with a two-color mixing ability test (28), where participants are given a two-colored chewing gum and are asked to chew the specimen for 20 chewing cycles. The resulting bolus is evaluated visually on a reference scale and opto-electronically using the Variance of Hue (VOH) (Halazonetis et al., 2013).
    Time Frame
    1-year
    Title
    Maximum voluntary bite force (MBF)
    Description
    The Gnathodynamometer DMD® (Kratos Equipamentos Industriais Ltda., Cotia - SP, Brazil) is utilized. It is a digital force gauge with an 8.6mm thick bite element. MBF is assessed bilaterally between the upper and lower first molar. The participant's task is to bite as hard as possible on the force gauge, but to stop clenching when she/ he starts feeling uncomfortable. A contra-lateral stabilizing element with identical thickness is used to preclude denture dislodgement. The peak force of three recordings carried out on each side will be used for analysis.
    Time Frame
    1-year
    Title
    Plaque index
    Description
    Measured at 4 sites per implant (mesial/distal/buccal/oral), according to the modified Mombelli's Plaque Index (Mombelli et al., 1987)
    Time Frame
    1-year
    Title
    Bleeding on probing
    Description
    Measured at 4 sites per implant (mesial/distal/buccal/oral), the following clinical parameters will be evaluated at baseline and each follow-up visit. Dichotomous score: yes x no
    Time Frame
    1-year
    Title
    Pocket probing depth
    Description
    Will be measured from the peri-implant mucosal margin to the bottom of the sulcus or pocket
    Time Frame
    1-year
    Title
    Width of the keratinized tissue
    Description
    The width of the keratinized tissue around implants will be measured and expressed in mm at the buccal sideated through a simple rule of three with NIH Image J V1.44.
    Time Frame
    1-year
    Title
    Peri-implant bone loss
    Description
    Intra-oral radiographs are exported and 4 parallel lines are drawn corresponding to the shoulder and the apical end of the implant on Adobe Photoshop Elements 2.0 (Adobe Systems Inc., San Jose, CA, USA). One line each is placed at the shoulder and apical end of the implant and the other two at the defined bone level on the mesial and distal aspect of the implant. Knowing the implant length and using the implant-shoulder as a reference point, bone levels can be calculated through a simple rule of three with NIH Image J V1.44.
    Time Frame
    1-year
    Title
    Implant Stability - Final insertion torque
    Description
    : after the implant is installed in its final position, the final torque of insertion will be recorded (Newtons per centimeter), as displayed during insertion with the handpiece, or measured using the manual calibrated torque gauge ratchet. Peak insertion torque: maximum achieved torque value during the implant insertion (in Newtons per centimeter). Periotest value: values will be categorized using the Periotest value ranges: 8 to 0: Good osseointegration; the implant can be loaded; 01 to 09: clinical examination is required; loading of the implant might or might not be possible, depending on implant type and clinical situation; 10 to 50: osseointegration is insufficient, the implant cannot be loaded.
    Time Frame
    1-year
    Title
    Implant Stability - Final insertion torque
    Description
    After the implant is installed in its final position, the final torque of insertion will be recorded (Newtons per centimeter), as displayed during insertion with the handpiece, or measured using the manual calibrated torque gauge ratchet.
    Time Frame
    During surgery
    Title
    Implant Stability - Peak insertion torque
    Description
    The maximum achieved torque value during the implant insertion (in Newtons per centimeter).
    Time Frame
    During surgery
    Title
    Implant Stability - Periotest value
    Description
    the Periotest® hand piece (Periotest®, Siemens AG, Bensheim, Germany) will be used with the head of the patient stabilized so that the implants were perpendicular to the floor, and the Periotest will be held parallel to the floor. The test point will be in the most gingival region of the Optiloc attachment, and each measurement will be performed 3 times and the average value will be recorded for each implant. In addition, values will be categorized using the Periotest value ranges: -8 to 0: Good osseointegration; the implant can be loaded; 01 to 09: clinical examination is required; loading of the implant might or might not be possible, depending on implant type and clinical situation; 10 to 50: osseointegration is insufficient, the implant cannot be loaded.
    Time Frame
    During surgery
    Title
    Implant Stability - Periotest value
    Description
    the Periotest® hand piece (Periotest®, Siemens AG, Bensheim, Germany) will be used with the head of the patient stabilized so that the implants were perpendicular to the floor, and the Periotest will be held parallel to the floor. The test point will be in the most gingival region of the Optiloc attachment, and each measurement will be performed 3 times and the average value will be recorded for each implant. In addition, values will be categorized using the Periotest value ranges: -8 to 0: Good osseointegration; the implant can be loaded; 01 to 09: clinical examination is required; loading of the implant might or might not be possible, depending on implant type and clinical situation; 10 to 50: osseointegration is insufficient, the implant cannot be loaded.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥ 60 years of age healed dentulous maxillary arch (minimum of twelve weeks since the last extraction) wearing a complete maxillary denture evaluated as sufficient for surgical planning minimal ridge dimensions of 5.4 mm (width) by 12 mm (height) in the anterior and premolar maxillary area bone dimensions allowing the placement of one-piece implants with a 2.4 mm-diameter and minimum length of 10 mm. general health condition should be a physical status ASA1 or ASA2. Exclusion Criteria: inability to perform adequate oral hygiene incapability to provide written informed consent and compliance to the protocol any contraindication for oral surgery such as but not limited to, uncontrolled diabetes immunosuppression radiation or chemotherapy antiresorptive medication such as bisphosphonates presence of dental, periodontal or peri-implant disease in the opposing arch presence of a conventional complete denture in the opposing arch (mandible) presence of an insufficient partial removable denture or implant-overdenture in the opposing arch, which cannot be rendered sufficient by a reline heavy smoking habit with > 20 cig/d reported severe bruxism or clenching habits clinically present oro-facial pain depression with a Geriatric Depression Scale above 12 xerostomia with a stimulated salivary flow rate inferior to 0.7 ml/min ridge morphology type IV (Cawood and Howell, 1988) defects requiring bone augmentation procedures, or unhealthy soft tissues.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cláudio R Leles, PhD
    Phone
    +5562981113302
    Email
    claudio_leles@ufg.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cláudio R Leles, PhD
    Organizational Affiliation
    Universidade Federal de Goias
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    35818640
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    Partially-guided Protocol for Maxillary Overdentures Retained by Ti-Zr One-piece Mini Implants

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